The Standards Institution of Israel

IS 4501 (2002)

The Standards Institution of Israel

Israeli Standard – IS 4501

Shevat 5762 – January 2002

Non-reusable containers for the collection of sharp medical items used in health care areas

This Standard, exclusive of the amendments and additions specified therein, is identical to Australian Standard AS 4031-1992

Amendment No. 1 – 1996

Descriptors: disposable, containers, sharps containers, medical equipment, health centres, medical supplies

This Standard was prepared by an expert committee, comprising the following members:

Reuben (Ruvi) Gilad, Dov Lev, Neil Friedman (Chairman), Pazit Rosenthal

The following participated in the preparation of the Standard:

Morris Luberblatt, Zali Maoz, Yehoshua Neumann, Uziel Zabari, Poriah Katlan, Ronnie Kleiner, Amos Rabinowitz

The Standard was approved by the Technical Committee 1408 – Rubber and Plastic Products for Medical Use, comprising the following members:

Kibbutz Industries Association-Aryeh Rotman

Federation of Israeli Chambers of Commerce- Yehoiakim Blutstein,
Joseph Levin

Israel Consumers Association-Inbal Karat

Manufacturers Association of Israel-Yossi Shahar, Dalit Tsur

Magen David Adom-Esther Manheimer

Israel Standards Institution – Manufacturers
Division-Orly Kornberg

Ministry of Health-Israel Paran (Chairman),
Fernandes Graor,
Fuad Janem

Naftali Pollack coordinated the preparation work for the Standard

Introduction to the Israeli Standard

This Israeli Standard is the Australian Standard AS 4031 (1992), including Amendment No.1 from August 1996, which was approved in its English version as the Israeli Standard, with certain amendments and additions.

The Hebrew version consists of:

-scope of the Standard with amendments and additions

-details of the amendments and additions to the Australian Standard

The Australian Standard, including Amendment No.1 to the Standard, is included in its English language version.

Scope of the Standard (Paragraph 1 of Australian Standard, with amendments and additions)

This Standard sets out requirements for non-reusable containers intended for the safe collection and transport of used sharp medical items, which are likely to be infectious, in health care areas, and are disposed of with their contents.

This Standard applies both to containers supplied as a single unit and to containers supplied as individual components (container with detachable cover). The containers to which this Standard applies are those designed to be assembled by the user and those that are supplied fully assembled.

2. Referenced documents

- Refer to the Paragraph “Referenced Documents” in the Australian Standard;

- The following Israeli Standards replace some of the Australian Standards referred to in the Referenced Documents paragraph, as hereunder:

Reference to Australian Standard / Replaced by Israeli Standard
AS 1319 / IS 2302 – Dangerous Substances and Preparations - Classification, Packaging, Labelling and Marking
AS 1946 / IS 1268 Section 1 – Syringes and Needles: Reusable all-glass or Metal and Glass Syringes for Medical Use - Dimensions

5. Design and Construction

5.1 Handle
This paragraph applies, with the following addition, which is to be inserted following the first sentence in the paragraph:
The handle or means of carrying the container shall not be an integral part of the cover. It shall be connected to the container in such a position and in such a manner as to prevent physical contact or proximity with the opening of the container.

- Following Paragraph 5.2, the following, designated Paragraph 5.2A, shall be added:

5.2A Detachable cover

In containers with a detachable cover, the mechanism by which the cover is connected to the body of the container shall be such as to prevent detachment of the cover from the container by means of reasonable force.

6.2 Resistance to penetration

This paragraph shall not apply, and shall be replaced by the following:

When tested in accordance with Appendix C, the average force required to penetrate any sample taken from any of the areas specified in Paragraph C4(a) shall be not less than 15 Newtons.

7. Colour

- The word “yellow” shall not apply, and shall be replaced by:
red.

(In other words, the colour of a container for the collection of waste, which is not radioactive, or which is not cytotoxic, shall be predominantly red.)

- The word “purple” shall not apply, and shall be replaced by:
green.
(In other words, the colour of a container for the collection of cytotoxic waste shall be predominantly green.)

- The word “red” shall not apply, and shall be replaced by:
yellow.

(In other words, the colour of a container for the collection of radioactive waste shall be predominantly yellow.)

-Following Paragraph 8, paragraphs 9 and 10 are to be added, as follows:

9. Hebrew marking

The container shall be clearly, legibly and durably marked in Hebrew, with all the information specified in Paragraph 8.

Imported containers:

(a)Shall also be marked with the name, and address of the importer, and the country of manufacture of the product.

(b)The size of the Hebrew letters and markings, and the area marked, shall be no less than the equivalent areas carrying the original markings of the manufacturer.

10. Additional requirements[1] for containers designated for moist heat sterilization (autoclave)

The container shall be made of materials suitable for moist heat pressure sterilization (such as: polypropylene, non-rust metal, e.g. stainless steel)).

APPENDIX A

A5. REPORT

(b) The reference to “AS 4031”shall not apply. It shall be replaced by:
IS 4501.

APPENDIX B

B3. (*)

Footnote *

The above footnote applies, with the addition of the following:

A surfactant solution equivalent to DECON-90 may be used.

B5. REPORT

(c)The reference to “AS 4031”shall not apply, and shall be replaced by:

IS 4501.

APPENDIX C

C4. TEST SAMPLE

(a) This paragraph shall not apply, and shall be replaced by:

Using the saw specified in Para. C3(d), or another suitable cutting instrument, cut 60 samples from the container, each measuring 12 mm X 12 mm; 12 from the base, 12 from the sidewalls, 12 from the closure device[2], 12 from the detachable cover (or from the upper portion of the container), apart from the closure device of the opening, and 12 from the corners and angles of the container.

If the size of the container does not allow for the required number of samples to be cut from a single container, the maximum possible number of samples should be cut from one container, and the remainder of the samples from a minimum number of other containers.

(b) The words “Cut a 25 mm X 25 mm test sample from each strip, and, “ do not apply.

C6. REPORT

(a) This paragraph shall not apply, and shall be replaced by:

The average force needed to penetrate the lower side of the sample is to be calculated from the results obtained in Para. C5, for each of the sample groups obtained from the areas specified in Para. C4(a).

(b)The reference to “AS 4031” shall not apply, and shall be replaced by:
IS 4501.

APPENDIX D

D6. REPORT

(c) The reference to “AS 4031” shall not apply, and shall be replaced by:
IS 4501.

Appendix E shall be added to the Standard, as follows:

Appendix E – Disposal of non-reusable containers for the collection of sharp medical items and their contents – moist heat sterilization (autoclave)

(For information only)

E1. Most non-reusable containers for the collection of sharp medical items, together with their contents, are sterilized by moist heat, so as to render their contents sterile before disposal at a waste disposal site.

E2. It is recommended that the following criteria apply to every container that undergoes moist heat sterilization:

1. Following the sterilization process there shall be no evidence of softening, cracking or degradation (e.g. dust on the outer surface, cracks or defects).
2. The cover of the container shall remain attached to the body of the container, and shall not become detached from it during or after the sterilization process.

E3. Confirmation of the efficacy of the moist heat sterilization process shall be in accordance with Israeli Standard IS 4335 - Sterilization of Health Care Products: Requirements for Validation and Routine Control of Moist Heat Sterilization in Health Care Facilities.

AS-4031-1992

Australian Standard®

______

Non-reusable containers for the

collection of sharp medical items

used in health care areas

______

(Title allocated by Defence Cataloguing Authority:

COLLECTION DISPOSAL CONTAINRES FOR HEALTH CARE

EQUIPMENT – NSC 6530)

PREFACE

This Standard was prepared by the Standards Australia Committee on Hypodermic and Other Equipment for General Medical Use, under the direction of the Multitechnics Standards Policy Board.

Cognisance has been taken of BS 7320:1990, Specification for sharp containers, in the development of this Standard.

The committee deliberated at length on the minimum penetration resistance of 12.5 N specified in Clause 6.2. This value was arrived at having regard to BS 7320, the draft Canadian Standard and local testing.

Reusable containers are not dealt with in this Standard, nor are “personal use” non reusable sharps containers issued in needle exchange programs.

CONTENTS

Page

1SCOPE 3

2REFERENCED DOCUMENTS3

3DEFINITIONS3

4MATERIALS3

5DESIGN AND CONSTRUCTION3

6PHYSICAL TESTS3

7COLOUR3

8MARKING4

APPENDICES

AMETHOD OF TEST FOR HANDLE INTERGRITY5

BMETHOD FOR DETERMINING IMPACT RESISTANCE6

CMETHOD FOR DETERMINING RESISTANCE TO PENETRATION7

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1

[1] See Appendix E

[2] Closure device – device used to close or seal the opening for the insertion of objects into an assembled, ready-to-use container